Enrollment in Study of Concentrated Saline for Traumatic Brain Injury Stopped

05/13/09  Portland, Ore.

The largest study of its kind, it found no difference in survival

The second portion of a clinical trial testing hypertonic saline in people with traumatic injuries has been stopped by the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH). The study found hypertonic saline was no better than the standard treatment of normal saline in treating patients with traumatic brain injuries (TBI) at the scene of an accident.

The study was testing whether hypertonic saline, water with a higher salt content than blood, or hypertonic saline with dextran, an added sugar molecule, could improve survival or brain function recovery in people with traumatic brain injuries as measured six months following injury. Hypertonic saline was believed to compensate for blood loss more effectively, lessen excessive inflammatory responses and prevent brain swelling.

In March, the NHLBI stopped a parallel study of hypertonic saline in trauma patients who went into shock due to severe bleeding because the highly concentrated saline solutions did not improve survival compared to standard saline solution. Both studies are part of the Resuscitation Outcomes Consortium (ROC), a group of 10 regional medical centers in the United States and Canada that seek to find promising scientific and clinical advances to improve survival from cardiac arrest and severe trauma. The traumatic brain injury study enrolled more than 1,000 participants, including 104 in the Portland metropolitan area. It is the largest randomized clinical trial ever conducted in this severely injured patient population.

“While we are disappointed these studies didn’t show any benefit for individuals with traumatic injuries, the knowledge we gained will contribute to our understanding of emergency medical care and may lead to new life-saving intervention strategies,” said Terri Schmidt, principal investigator of the Greater Portland ROC site and professor of emergency medicine in the OHSU School of Medicine.

The NHLBI stopped enrollment in the TBI study based on a recommendation by the independent Data and Safety Monitoring Board (DSMB), an independent group of physicians that monitors ROC studies. The DSMB reviewed an interim analysis of data on 1,073 patients who had been followed for six months – about half of the total number of patients the researchers had planned to enroll. They found no differences in the benefits or risks of either of the two hypertonic saline solutions compared to normal saline. In addition, there was no evidence that either of the hypertonic saline solutions was harmful to these patients. 

“We are grateful for the wonderful work and dedication our local emergency medical services personnel put into these studies,” said Portland ROC co-investigator Mohamud Daya, M.D., associate professor of emergency medicine in the OHSU School of Medicine. “These studies wouldn’t have been possible without the help of the EMS providers and the area trauma hospitals where individuals enrolled in the study were transported.”

Individuals eligible for enrollment in ROC studies are unable to provide consent to be in a research study due to the nature of their conditions.  Because of this, the studies are being conducted under Food and Drug Administration (FDA) guidelines that allow research in certain life-threatening situations without pretreatment authorization.

Currently emergency medical services agencies across North America use slightly varying methods to treat patients. The ROC allows studies to be conducted in rural and urban areas simultaneously, thus allowing a large number of diverse individuals to be enrolled and results to more quickly guide future practice.

In addition to clinical trials, the ROC has established the world's largest data registry of pre-hospital cardiac arrest and life-threatening trauma, which will enable researchers to identify best practices to improve resuscitation success. To date, more than 50,000 cardiac arrest subjects and 14,000 trauma subjects have been enrolled.

OHSU continues to enroll people in another ROC exception from informed consent study testing methods of resuscitating victims of cardiac arrest. Any community member who does not wish to be included in this or any future exception from informed consent studies can request a medical alert bracelet with the words “No Study” by calling 503 494-8083 or emailing roc@ohsu.edu with a full name and mailing address. More information about ROC can be found at: www.ohsu.edu/emergency/roc

The NHLBI is the lead sponsor of the ROC studies with additional funding provided by the NIH’s National Institute of Neurological Disorders and Stroke, the Institute of Circulatory and Respiratory Health of the Canadian Institutes of Health Research, U.S. Army Medical Research & Materiel Command, American Heart Association, Defence Research and Development Canada, and the Heart and Stroke Foundation of Canada.

About OHSU                          

Oregon Health & Science University is the state’s only health and research university, and Oregon’s only academic health center. OHSU is Portland's largest employer and the fourth largest in Oregon (excluding government). OHSU's size contributes to its ability to provide many services and community support activities not found anywhere else in the state. It serves patients from every corner of the state, and is a conduit for learning for more than 3,400 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to every county in the state.